Cognitive Function
Conditions
Brief summary
The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.
Interventions
DIETARY_SUPPLEMENT3 g PronovaPure 150:500 EE EU
DIETARY_SUPPLEMENT3 g PronovaPure 500:200 EE EU
DIETARY_SUPPLEMENT3 g Placebo
Sponsors
Pronova BioPharma
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 25 to 49 years inclusive * Males and females * Self-report of good health
Exclusion criteria
* English is not first language (some of the cognitive tasks have only been validated in native English speakers) * Habitual consumption of oily fish exceeds one fish meal per week * Habitual consumption of omega-3 dietary supplements in the previous 6 months * Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure) * Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes) * Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff * Pregnant, trying to get pregnant or breast feeding * Body Mass Index outside of the range 18-35 kg/m2 * High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg) * Currently taking blood pressure medication * Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin) * Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study) * Have frequent migraines that require medication (more than or equal to 1 per month) * History or current diagnosis of drug/alcohol abuse * History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation * History of neurological or psychiatric illness (excluding depressive illness and anxiety) * History of head trauma * Sleep disturbances and/or are taking sleep aid medication * Blood disorders (e.g. anaemia, haemophilia, thrombocytosis) * Diagnosis of type I or type II diabetes * Heart disorder, or vascular illness * Current diagnosis of depression and/or anxiety * Over- or under-active thyroid * Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease) * Any known active infections * Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus * Current or past breast cancer diagnosis and/or a mastectomy * Health condition that would prevent fulfilment of the study requirements * Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective fatigue | 26 weeks | Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire |
| Episodic memory | 26 weeks | An overall score for Episodic memory will be derived by calculating the average score from 6 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy - Zimmediate word recall errors - Zdelayed word recall errors)/6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective vigour | 26 weeks | Subjective vigour will be derived from the Vigour subscale of the Profile of Mood States questionnaire |
| Subjective confusion | 26 weeks | Subjective confusion will be derived from the Confusion subscale of the Profile of Mood States questionnaire |
| Subjective anger | 26 weeks | Subjective anger will be derived from the Anger subscale of the Profile of Mood States questionnaire |
| Subjective tension | 26 weeks | Subjective tension will be derived from the Tension subscale of the Profile of Mood States questionnaire |
| Subjective alertness | 26 weeks | Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance |
| Numeric Working memory | 26 weeks | Reaction time (ms) |
| Simple reaction time | 26 weeks | — |
| Stroop task | 26 weeks | Reaction time (ms) |
| Rapid visual information processing | 26 weeks | Reaction time (ms) |
| Verbal fluency | 26 weeks | Number correct |
| Subjective mental fatigue | 26 weeks | Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance |
| Subjective overall mood disturbance | 26 weeks | Subjective overall mood disturbance is derived from the overall score of the Profile of Mood States questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Omega-3 index | 26 weeks | Omega-3 index is expressed as the sum of EPA and DHA as a percentage of total red blood cell fatty acids |
Countries
United Kingdom
Outcome results
None listed